This application is a continuation-in-part of application Ser. No. 10/919,800, filed Aug. 17, 2004.
The invention concerns authentication and tracking of medical pills (including pills that dissolve under the tongue or under the skin), or external medications such as skin patches, or implantable medicaments (all sometimes referred to herein as biomedical dosage units), using an embedded or attached radio frequency identification (RF ID) tag which is very small in size, on the order of about one millimeter, with no onboard battery or other constant power supply.
U.S. Pat. No. 6,480,699 describes a radio frequency identification (RF ID) tag sufficiently small to be incorporated very small within objects, even paper money. The RF ID tag includes an onboard antenna, preferably part of the same integrated circuit platform with the tag electronics. The tag acts is a transponder using the power of an interrogating signal to collect and store energy for use in transmitting a responding signal which is preferably unique to the particular tag.
The above described U.S. Pat. No. 6,480,699 mentions a number of applications for the miniature RF ID tag, which may be less than 1 mm in plane dimensions, and may be less than 0.5 mm in thickness.
In the pharmaceutical industry, there is a need for a system to accurately track pills (or other biomedical dosage units), not necessarily by a code unique to each individual pill, but by a code applied to each different type of pill. A corollary is to authenticate pills to prevent counterfeiting helping grey-market importing and other measures taken in the market place to sidestep marketing path intended by the proprietary manufacturer. Going even further, each batch of a certain pharmaceutical pill could advantageously have a unique identifier, so that the batch could be tracked electronically from manufacture until retail sale or even beyond, and each individual pill can even carry a unique identifier different from all other similar pills, useful for counting pills, in or out of a container.
There is a need to track, trace and authenticate pharmaceuticals which are in easily counterfeited, diverted and otherwise alterable forms such as pills, tablets, capsules, implantable medicaments, skin patches and other unit dosages. On Feb. 25, 2004, the Food and Drug Administration (FDA) published a final rule entitled, “Bar Code Label Requirements for Human Drug Products and Biological Products”. Their objective was to improve patient safety in the hospital setting by reducing medication errors. The means to their objective was to require “bar codes” on most prescription drugs and on certain over-the-counter drugs. Bar codes are symbols consisting of parallel lines and spaces and are commonly seen on most consumer goods. In retail settings, bar codes identify the specific product and allow software to link the product to price and other sales-and inventory-related information. FDA's bar code rules uses bar codes to address an important public health concern—medication errors associated with drug products. Concurrent with this was an FDA mandate to curtail the number of counterfeit drugs by also using bar code technology. Bar coding is however, highly inaccurate, subject to humidity, and climate conditions, unable to be utilized if out of the line of sight to the reader and unable to effectively be useful on single unit dosages. Replacement of bar coding with RF ID in medical applications is not new, but the use of a small and powerful enough, all-in-one tag on or within the pill, capsule, tablet or dosage is exclusive to this invention and meets both FDA objectives.
It is an object of this invention to provide a system which makes such authentication and tracking of medical pills possible, efficient and cost effective.